MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 1231 1K 2.25CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	08-1231-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: the reported information, which included a report that the patient went to the hospital due to shortness of air (soa) due to the 1k bath of naturalyte during hemodialysis (hd) treatment, was reviewed.The nurse does not have any documentation of the patient going to the hospital or receiving a computed tomography (ct) scan.Follow up with the hemodialysis center nurse documented that this patient has a history of paranoia.The nurse stated that the patient completed all hd treatments for the month of january, as well as prior to january and to date, with no reported issues.There were no other patients that reported any issues in regards to the 1k bath during treatment.Based on the available information there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issues warranting further clinical investigation.Should additional information become available, the clinical investigation will be reassessed and supplemental report submitted accordingly.
Event or Problem Description
A user facility clinic manager reported that a patient alleged experiencing shortness of air (soa) due to their 1k bath with naturalyte.The clinic manager stated that the patient reported this issue to have occurred sometime in january, however, the exact date was not provided.The clinic manager confirmed that the patient has completed all treatments within the time period at the clinic without any reported issues.Furthermore, no other patients have had any issues related to the use of naturalyte.The patient reported to the clinic manager that they went to the hospital where they received a ct scan which subsequently opened their blood vessels and relieved their shortness of air.Further hospital details were requested, however, were not available as they were not provided to the facility.The clinic manager reported that the patient has a history of paranoia.The lot number of the naturalyte was unknown.The patient has since returned to the clinic and received treatments without further issue or reoccurrence of the reported issue.
Additional Manufacturer Narrative
Plant investigation: the complaint product was not returned for investigation, therefore, the reported event could not be confirmed.Since no lot number was able to be confirmed, shipping records were reviewed to identify the lot number of the complaint product.The search provided all lot numbers delivered to the customer clinic in the three months prior to the complaint occurrence date.There were 4 lots identified.Product retains of the lots potentially involved were tested and found to be within specification.A records review was performed on the lot numbers.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the complaint was unable to be confirmed.

• Brand Name: NATURALYTE 1231 1K 2.25CA 1MG GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; 750 n lallendorf road; oregon OH 43616
• MDR Report Key: 7344908
• Report Number: 3005162618-2018-00001
• Device Sequence Number: 18841087
• Product Code: KPO
• UDI-Device Identifier: 00840861101641
• UDI-Public: 00840861101641
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K981043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 08-1231-3
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Weight: 93